Liver Cancer Clinical Trial
Official title:
Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of
liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib
tosylate is more effective when given alone or together with pravastatin in treating patients
with liver cancer and cirrhosis.
PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with
pravastatin to see how well it works compared with giving sorafenib tosylate alone in
treating patients with liver cancer and cirrhosis.
OBJECTIVES:
Primary
- To evaluate the effects of sorafenib tosylate and pravastatin versus sorafenib tosylate
alone on overall survival of patients with hepatocellular carcinoma and Child-Pugh Class
A cirrhosis.
Secondary
- To evaluate the effect of this regimen on progression-free survival, time to
progression, time to treatment failure, and quality of life (QLQ-C30 and FACT hep) in
these patients.
- To evaluate the benefit of on-site monitoring versus the centralized data management
monitoring of these patients.
- To characterize polymorphisms to specify the haplotype diversity in these patients.
- To test both diagnostic and prognostic signatures by quantitative RT-PCR to determine if
they can predict response to these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, Cancer of the Liver Italian Program (CLIP) score (0 vs 1 vs 2-4), WHO performance
status (0 vs 1 vs 2), portal vein thrombosis (presence vs absence), and extrahepatic
metastases (presence vs absence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily on days 1-28 and oral
pravastatin once daily on days 1-28. Courses repeat every 4 weeks in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires (QLQ-C30 and FACT) at baseline and then
every 4 weeks during and after completion of study therapy.
Blood and tissue samples may be collected for laboratory analysis, including pharmacogenomic
studies.
After completion of study therapy, patients are followed up periodically.
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